- CSR Summary Not Available
- NCT03434041
- Primary Citation Trial has yet to be published
- Data Specification Not Available
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Trial Information
Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous System DiseasesEnrollment252% Female44.8%% White8.3%
Product ClassNMDA receptor antagonistSponsor Protocol NumberESKETINTRD3006Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, Treatment-ResistantMean/Median Age (Years)37.3
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0612 : Effects of ketamine and esketamine on death, suicidal behavior and suicidal ideation in psychiatric disorders: A systematic review and meta-analysis
- 2023-5230 : Esketamine for treatment-resistant depression in adults: Cochrane systematic review and meta-analysis on efficacy and tolerability of esketamine
- 2023-5149 : Sex Differences in the Antidepressant Effects of Ketamine
- 2021-4851 : Efficacy of esketamine for "treatment resistant depression" assessed by MADRS score after at least 4 weeks, an IPD meta-analysis